• Acacia Research Corp., of Newport Beach, Calif., said it has obtained commitments to purchase $2.9 million of its Acacia Research/CombiMatrix common stock in a registered direct offering. Acacia will sell about 1.3 million shares of its stock at $2.25 a share to a select group of institutional investors. The closing is expected July 5.

• Acorda Therapeutics Inc., of Hawthorne, N.Y., initiated a Phase III trial of Fampridine-SR in multiple sclerosis. The 240-patient study, based on a special protocol assessment issued by the FDA in May, will evaluate whether the drug significantly improves walking ability. Secondary outcomes include measurements of leg strength and muscle spasticity. Fampridine-SR is a sustained-release tablet formulation of fampridine. (See BioWorld Today, May 5, 2005.)

• Agensys Inc., of Santa Monica, Calif., submitted an investigational new drug application to initiate a Phase I trial with AGS-PSCA. AGS-PSCA is a fully human monoclonal antibody with potential in prostate, pancreatic and bladder cancers, the company said. Agensys plans to focus the initial Phase I trial on patients with advanced prostate cancer. AGS-PSCA is a high-affinity, human IgG1k MAb directed to Agensys' target prostate stem cell antigen.

• Arena Pharmaceuticals Inc., of San Diego, said top-line Phase I results showed that APD125, an oral drug for insomnia, was well tolerated at all doses investigated. The data also demonstrated a statistically significant increase in the amount of deep, or slow wave, sleep and a positive signal in other sleep maintenance parameters. The company added that the compound, a selective inverse agonist of the 5-HT2A serotonin receptor, also might have extended sleep onset latency in normal volunteers in the 45-subject study.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., initiated enrollment of patients with recurrent or persistent endometrial cancer in a global Phase II trial of its mTOR inhibitor, AP23573, as a single agent. The non-randomized study will evaluate the clinical benefit of AP23573 in well-characterized endometrial cancer patients. Up to about 45 patients will be enrolled.

• AVI BioPharma Inc., of Portland, Ore., submitted an investigational new drug application for its Neugene antisense drug, AVI-4065, targeting hepatitis C virus. The initial Phase Ib trial will include up to 50 patients in three treatment groups: normal subjects and two groups of patients with chronic, active HCV, including patients who are newly diagnosed and those who have failed the current standard of care, which is interferon and ribavirin.

• Axonyx Inc., of New York, said that Marvin Hausman has elected to step down as chairman on Sept. 14 but will remain a director. The board unanimously elected Steven Ratoff as nonexecutive chairman to succeed Hausman. Hausman founded the company in 1997. Axonyx is focused on the acquisition and development of pharmaceutical compounds for the treatment of central nervous system disorders.

• Barrier Therapeutics Inc., of Princeton, N.J., said its oral antifungal product candidate, Hyphanox, failed to meet the primary endpoint in a Phase III noninferiority trial for the treatment of vaginal candidiasis. Results showed that 26 percent of the subjects treated with Hyphanox reached the primary efficacy endpoint - patients who had a therapeutic cure at 25 days post-treatment - as compared to the 37 percent treated with fluconazole. Barrier's stock (NASDAQ:BTRX) dropped 46.4 percent Thursday, or $6.85, to close at $7.93.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said the second Phase III induction trial of Tysabri (natalizumab) in moderately to severely active Crohn's disease in patients with evidence of active inflammation met its primary endpoint of clinical response as defined by a 70-point decrease, as measured at weeks eight and 12 using the Crohn's Disease Activity Index. In addition, Tysabri met all secondary endpoints in the ENCORE trial, and there were no notable differences in the rates of adverse events between the Tysabri and placebo treatment groups. All patients enrolled in the ENCORE trial completed dosing prior to the voluntary market withdrawal of Tysabri in February by Biogen and Elan, due to a possible link to two cases of progressive multifocal leukoencephalopathy, a potentially fatal nervous system disease. Researchers continue to investigate safety issues relating to Tysabri.

• Cellegy Pharmaceuticals Inc., of Brisbane, Calif., said the FDA is continuing its review of the company's recently submitted amended new drug application for Cellegesic (0.4 percent nitroglycerin ointment), a product for treating pain associated with chronic anal fissures. The company added that it expects the agency to respond soon after the review is complete. Previously, the FDA issued a not-approvable letter on an initial marketing application. (See BioWorld Today, Dec. 28, 2004.)

• Children's Hospital of Pittsburgh and the University of Pittsburgh said researchers identified a specific pathway that causes inflammation in lung tissue, which could lead to targeted treatments for diseases such as cystic fibrosis. Researchers measured mediators of inflammation in cystic fibrosis patients, focusing on interleukin-23 and interleukin-17, and found that those targets might be useful in blocking the inflammatory response. The results are being published in the July issue of The Journal of Immunology.

• Codexis Inc., of Redwood City, Calif., and Cargill Inc., of Minneapolis, hit a milestone in their collaboration to develop a platform for the conversion of agricultural raw materials to polymers, materials and other industrial chemicals. The partners are producing a chemical intermediate known as 3-hydroxypropionic acid (3-hp) from non-petroleum, natural raw materials. Codexis received research funding and milestones payments from Cargill under their agreement, and could receive additional funding. Codexis also is eligible for additional milestone payments and sales royalties upon successful commercialization. Specific financial terms were not disclosed.

• Diversa Corp., of San Diego, and Valley Research Inc., of South Bend, Ind., launched their Ultra-Thin enzyme product for ethanol production. Developed by Diversa and marketed by Valley Research, they said it operates at high temperatures and at pH 4.5, a lower pH than other commercially available enzymes.

• DOV Pharmaceutical Inc., of Hackensack, N.J., said that Leslie Hudson will become the company's CEO and president and is expected to start by the end of July. DOV's co-founder, Arnold Lippa, currently chairman, CEO and president, will continue to serve as chairman. Hudson has served in senior level leadership positions at Pharmacia Corp. and Glaxo Inc. DOV is a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of drug candidates for central nervous system and other disorders.

• ExonHit Therapeutics SA, of Paris, added a fifth array product to its SpliceArray Service business unit with the addition of Cytokine SpliceArrays.

• Genaera Corp., of Plymouth Meeting, Pa., initiated the first of two planned Phase III trials of is systemically administered anti-angiogenic drug, Evizon (squalamine lactate), for the treatment of wet age-related macular degeneration. The identical studies, which will evaluate the drug in two doses vs. placebo, are designed to demonstrate safety and significant clinical benefit of Evizon therapy on visual acuity at one year. The FDA approved Genaera's special protocol assessment for Evizon's pivotal program in June. (See BioWorld Today, June 28, 2005.)

• Genencor International Inc., of Palo Alto, Calif., released a new product from its line of Stargen granular starch hydrolyzing enzymes, representing a new enzyme technology for the ethanol industry that the company said could lead to improved energy balance and reduced production costs while obtaining higher output. Specifically, Genencor's Stargen enzymes include blends of an alpha amylase and a glucoamylase that convert granular or uncooked starch to fermentable sugars on a continuous basis through a simultaneous saccharification and fermentation process.

• Genta Inc., of Berkeley Heights, N.J., began submitting a new drug application to the FDA for accelerated approval of Genasense (oblimersen sodium) Injection in combination with fludarabine plus cyclophosphamide for chronic lymphocytic leukemia patients who previously have received fludarabine. The agency already has designated the drug a fast-track product in that indication. At the same time, the company filed a formal letter of intent with the European Medicines Agency as the initial step for submitting a marketing application for Genasense plus dacarbazine for chemotherapy-na ve metastatic melanoma patients.

• Genzyme Corp., of Cambridge, Mass., and shareholders of Bone Care International Inc., of Middleton, Wis., approved the company's acquisition by Genzyme, effective July 1. Genzyme announced in May it planned to acquire Bone Care in an all cash transaction valued at $33 per share, or about $600 million. (See BioWorld Today, May 5, 2005.)

• Gilead Sciences Inc., of Foster City, Calif., said that data through 144 weeks supporting the efficacy and tolerability of its oral antiviral drug, Hepsera (adefovir dipivoxil), in patients chronically infected with hepatitis B "e" antigen-negative chronic hepatitis B were published in the June 30, 2005, issue of The New England Journal of Medicine. Continued viral suppression and changes in laboratory markers of liver function were evaluated through three years.

• Halozyme Therapeutics Inc., of San Diego, submitted its Phase I investigational new drug application for Chemophase to the FDA. Chemophase is a formulation of recombinant human hyaluronidase being developed as a chemoadjuvant for the treatment of cancer.

• Immunicon Corp., of Huntingdon Valley, Pa., completed its sale of 4.1 million shares of common stock for gross proceeds of $19.7 million. Shares were sold to institutional investors at a price of $4.75 per share. The proceeds will be used to further the development and commercialization of the company's cancer diagnostic products, as well as supporting the development of products outside the field of cancer.

• MediGene AG, of Martinsried, Germany, said results of a Phase II trial of its Polyphenon E Ointment (15 percent) for the treatment of actinic keratosis, a precursor of skin cancer, showed that the drug demonstrated immunomodulatory properties, though the chosen treatment regimen and trial length were not sufficient for complete healing of all visible skin lesions on patients' scalps and faces. The company said it plans to continue with clinical development after determining an optimal dosage plan.

• Morphotek Inc., of Exton, Pa., broadened its agreement with Deerfield, Ill.-based Baxter Healthcare Corp. to support the development and manufacture of its antibody pipeline. The extended agreement will reserve capacity for the manufacturing of Morphotek's lead compound, MORAb-003, which is in Phase I studies for ovarian cancer. Existing agreements cover the manufacturing of MORAb-009, in development for pancreatic cancer, and MORAb-004, which targets an antigen related with neovascular disease.

• Neurochem International Ltd., of Ecublens, Switzerland, said the FDA agreed to file and review a new drug application for Fibrillex that would include efficacy and safety data from a single Phase II/III trial. The investigational product candidate, developed for treating amyloid A amyloidosis, is the subject of an exclusive collaboration and distribution agreement with Centocor Inc., of Malvern, Pa. The regulatory news follows a recent meeting with the FDA's cardio-renal division to discuss results of that Phase II/III trial, and the agency encouraged Neurochem to look at and provide additional follow-up data collected from the open-label extension study as part of its submission. The company is a wholly owned subsidiary of Neurochem Inc., of Laval, Quebec.

• Neurome Inc., of San Diego, said it was selected for a grant offer from the Foundation for the National Institutes of Health through the Grand Challenges in Global Health Initiative, a project supported by $436 million and launched by the Bill & Melinda Gates Foundation in 2003. The three-year project, aimed at addressing the development of a needle-free vaccine delivery system, will investigate the application of Neurome's TOGA gene discovery tools.

• NV Organon, of Oss, the Netherlands, agreed to collaborate with Cypress Bioscience Inc., of San Diego, to develop and commercialize a treatment for obstructive sleep apnea. The collaboration will involve an enantiomer of mirtazapine, ORG 4419, and combinations of mirtazapine with another approved drug to augment efficacy and improve tolerability. The companies jointly will select a development candidate based upon proof-of-concept trials, and then share costs and responsibility for further clinical activities. Further financial terms were not disclosed. In other news, Organon also announced a global biotechnology discovery research initiative with a Boston seminar, and opened the doors to its new Cambridge, Mass.-based research center June 29.

• OriGene Technologies Inc., of Rockville, Md., received a Phase I Small Business Innovation Research grant from the National Institutes of Health through the National Human Genome Research Institute to validate its short-hairpin RNA Kinome collection. OriGene provides technologies for large-scale gene function analyses.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said its diabetes and obesity business unit, Prosidion, granted Whitehouse Station, N.J.-based Merck & Co. Inc. a worldwide, nonexclusive license for patents claiming combination therapy of a DPIV inhibitor plus another therapeutic agent for the treatment of Type II diabetes and related indications. OSI will receive up-front, milestone and royalty payments. Additional terms were not disclosed.

• Perlegen Sciences Inc., of Mountain View, Calif., is conducting a high-density whole-genome scan of single nucleotide polymorphisms in relation to coronary heart disease, stroke and breast cancer, and combined postmenopausal hormone therapy in collaboration with the Women's Health Initiative. The study aims to provide insight into the genetic contribution to the three chronic diseases, and to relate the findings to the effects of estrogen plus progestin therapy.

• Pharming Group NV, of Leiden, the Netherlands, is partnering with AgResearch Ltd., of Hamilton, New Zealand, on the production of recombinant human lactoferrin (rhLF). AgResearch, which will be responsible for the production of rhLF and will provide access to its purification and research capabilities for product development, will bear costs associated with rhLF's initial production and support its commercialization in the South Pacific and Asia. At the same time, Pharming granted AgResearch a research license to its recombinant protein production technology. In return, Pharming will have the first right to review new products from AgResearch's protein discovery and development projects. Pharming's commercial rights will include recombinant bovine and human proteins produced using its technology.

• Procyon Biopharma Inc., of Montreal, closed its acquisition of Bioxalis Medica Inc., also of Montreal, concurrent with a non-brokered $3.5 million financing by way of a private debt placement. Procyon traded 9 million common shares for all of Bioxalis' outstanding securities, and also granted Bioxalis' shareholders warrants to 1 million more Procyon shares at market price at the time of exercise. They will become vested upon filing of an investigational new drug application for TVT-Dox, Bioxalis' lead product, on or before March 15, 2007. As to the financing, the $1,000 face value debentures are unsecured obligations of Procyon, have a 7 percent coupon and are convertible, in whole or in part, into Procyon shares at 45 cents apiece. Procyon was advised in the acquisition by Dundee Securities Corp., which also pocketed a finders fee in the debt sale.

• Protea Biosciences Inc., of Morgantown, W.Va. said it launched new protein identification services for the biotechnology and pharmaceutical research industry that offer improved capability to identify proteins in complex mixtures and to generate protein databases.

• Qiagen NV, of Venlo, the Netherlands, entered an agreement to acquire Nextal Biotechnology Inc., of Montreal, in exchange for $9.7 million in cash. An additional consideration of about $4.5 million is subject to certain milestones. Nextal provides sample preparation tools that make protein crystallization more accessible, while Qiagen sells preanalytical sample preparation products enabling genetic and protein analysis. Gargoyle Partners LLP acted as Qiagen's exclusive financial adviser.

• Targacept Inc., of Winston-Salem, N.C., said its compounds were reported to have a beneficial effect on cognition well after they were no longer present in the central nervous system. In preclinical animal studies, compounds TC-1827 and TC-1734 improved cognitive performance for up to 15 and 18 hours, though the compounds were appreciably metabolized and eliminated in less than an hour. The results were published in the July 2005 issue of Trends in Pharmacological Sciences.

• TmBioscience Corp., of Toronto, signed a five-year agreement to supply custom Tag-It reagents to InterGenetics Inc., of Oklahoma City, for OncoVue, a genetic-based breast cancer risk test. The agreement anticipates InterGenetics will purchase a minimum of $7.5 million in reagents from Tm over the five-year period. In other news, Tm said it has received a total of $3.8 million since the end of the first quarter from the exercise of warrants and compensation options relating to two private placements, closed on June 26, 2003, and Dec. 22, 2003. Proceeds are expected to fund Tm's pipeline of genetic tests.

• V.I. Technologies Inc., of Watertown, Mass., said it plans to discontinue direct investment in the development of the Inactine system for red blood cells, and will begin efforts to license the technology and intellectual property to potential partners. The company intends to focus its resources on the development and commercialization of antiviral therapeutics based on the platform acquired earlier this year through its merger with Gaithersburg, Md.-based Panacos Pharmaceuticals Inc. (See BioWorld Today, March 11, 2005.)

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